COVID-19 Antigen Home Test Package Insert

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2 X5x54xseconds squeezing the tube COVID-19 Antigen Home Test Package Insert for Healthcare Providers REF L031-118B5 REF L031-125M5 REF L031-125N5 REF L031-125P5 English A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. For in vitro diagnostic use only. For Emergency Use authorization only. INTENDED USE The Flowflex COVID-19 Antigen Home Test is a rapid lateral flow immunoassay intended for the qualitative detection of the nucleocapsid protein Antigen from SARS-CoV-2.

3 This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal swab samples from individuals aged 2 or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

4 The Flowflex COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein Antigen . Antigen is generally detectable in nasal (nares) samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the Flowflex COVID-19 Antigen Home Test should self-isolate and consult their physician or healthcare provider as additional testing may be necessary.

5 Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of an individual s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 . For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection.

6 Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection. Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care from their healthcare provider. Individuals should provide all results obtained with this product to their healthcare provider for public health reporting. Healthcare providers will report all test results they received from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.

7 The Flowflex COVID-19 Antigen Home Test is intended for non-prescription self-use and/or as applicable an adult lay user testing another aged 2 or older. The Flowflex COVID-19 Antigen Home Test is only for use under the Food and Drug Administration s Emergency Use authorization . SUMMARY AND EXPLANATION The novel coronaviruses belong to the genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough.

8 Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. PRINCIPLE The Flowflex COVID-19 Antigen Home Test is a qualitative membrane based chromatographic immunoassay for the qualitative detection of the nucleocapsid protein Antigen from SARS-CoV-2 in human anterior nasal swab specimens. When specimens are processed and added to the test cassette, SARS-CoV-2 antigens, if present in the specimen, will react with the colored anti-SARS-CoV-2 antibody-coated particles, which have been pre-coated on the test strip. The Antigen -antibody complex then migrates toward the membrane by capillary action. This complex is then captured by anti-SARS-CoV-2 monoclonal antibodies immobilized at the test line region, and a colored line appears on the membrane.

9 Test results are interpreted visually at 15-30 minutes based on the presence or absence of visually colored lines. To serve as a procedure control, a red or pink line will always appear in the control line region after proper volume of specimen has been added, and membrane wicking has occurred. REAGENTS The test cassette contains anti-SARS-CoV-2 antibodies. PRECAUTIONS Read the COVID-19 Antigen Home Test Package Insert carefully before performing a test. Follow directions for use. Failure to follow directions may produce inaccurate test results. For in vitro diagnostic use. This product has not been FDA cleared or approved but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

10 The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. This product has been designed only for the detection of SARS-CoV-2 Antigen , not for any other viruses or pathogens. False negative test results may occur if a specimen is incorrectly collected or handled. To obtain accurate results, the test must be performed as indicated in this Instructions for Use. INVALID RESULTS, indicated by no Control Line, can occur when an insufficient volume of sample solution is added to the test cassette.